Clinical trial · Observational
Safety and Efficacy of Transarterial ICG Fluorescence-Guided Laparoscopic Anatomical Liver Resection
Safety and Efficacy of Trans-arterial Versus Trans-portal ICG Fluorescence-Guided Laparoscopic Liver Watershed Resection: A Multicenter, Ambispective Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This multicenter, ambispective cohort study evaluates the safety and efficacy of trans-arterial Indocyanine Green (ICG) fluorescence-guided laparoscopic liver watershed resection for Hepatocellular Carcinoma (HCC). The study aims to compare the outcomes of the trans-arterial ICG staining approach versus the conventional trans-portal (portal vein) ICG staining approach.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic Anatomical Liver Resection (guided by transarterial injection of ICG) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Transarterial ICG Group
- description
- Patients who underwent laparoscopic anatomical liver resection guided by superselective transarterial injection of ICG.
- interventionNames
- Procedure: Laparoscopic Anatomical Liver Resection (guided by transarterial injection of ICG)
- label
- Transportal ICG Group
- description
- Patients who underwent laparoscopic anatomical liver resection guided by transportal (portal vein) injection of ICG.
Primary outcomes (1)
- measure
- Recurrence-Free Survival (RFS)
- timeFrame
- Up to 18 months post-surgery (assessing the 18-month RFS rate as a key benchmark)
- description
- RFS is defined as the time interval from the date of surgery to the date of first documented tumor recurrence (intrahepatic or extrahepatic) or death from any cause. Evaluated using Kaplan-Meier analysis.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-80 years. 2. Postoperative histopathological diagnosis of Hepatocellular Carcinoma (HCC). 3. Underwent ICG fluorescence-guided laparoscopic anatomical liver resection. 4. Child-Pugh Class A or B. 5. ASA score I-III. 6. ECOG Performance Status 0-2. 7. No invasion of major vessels (main portal vein/first-order branches, main hepatic vein). 8. No distant metastasis. Exclusion Criteria: 1. Pathology confirms non-HCC components (e.g., cholangiocarcinoma, combined HCC-ICC) or metastatic liver cancer. 2. Concomitant other active malignancies. 3. Preoperative anti-tumor therapy (TACE, ablation, radiotherapy, systemic therapy) or history of prior hepatectomy. 4. Ruptured tumor. 5. Conversion to open surgery. 6. Unclear surgical records regarding ICG staining method. 7. Intraoperative ICG staining failure (e.g., diffuse staining, unclear boundaries) preventing fluorescence-guided resection. 8. Missing data preventing primary endpoint assessment.
References
Publications (0)
Data not yet available